Post-operative Pain Management in Children With Supracondylar Humerus Fractures

Stopped early · Phase 4

Conditions studied: Supracondylar Humerus Fracture

In brief

There are two common and concurrently used strategies for pain management following surgical treatment of supracondylar humerus (elbow) fractures in children: opioids vs over the counter pain medications. The purpose of this study is to determine if ibuprofen and acetaminophen can provide similar or better pain relief compared to ibuprofen and hydrocodone/acetaminophen (also known as Hycet) for this population of children after they have been discharged. If over the counter medications can provide adequate pain relief, then fewer opioid prescriptions would be necessary. This reduces early opioid exposure and decreases unnecessary opioids in circulation.

Key facts

Study ID

NCT05640674

Run by

Baylor College of Medicine

People needed

29

Starts

2023-09-12

Expected to finish

2025-12-15

Last updated by the study team

2026-02-10

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Closed, Gartland type III supracondylar humerus fracture
• Fractures treated with closed reduction and percutaneous pinning (CRPP)
• Patients expected to follow up at Texas Children's Hospital
• Patients/guardians must speak English or Spanish

You may not qualify if…

• Fractures associated with open skin wounds, polytrauma, neurologic deficit, or vascular deficit
• Patients who have impaired ability to report pain severity such as intellectual delay.
• Patients who have a problem with bone healing such as osteogenesis imperfecta.
• Patients who are unable to take the standard dose of acetaminophen, ibuprofen, or hydrocodone (allergy, severe kidney disease, etc).
• Patients who are on chronic NSAID or opioid medication prior to injury.
• Patients with injury from suspected non-accidental trauma.

Where it is running

• Texas Children's Hospital - Main Campus — Houston, Texas, United States
• Texas Children's Hospital - West Campus — Houston, Texas, United States
• Texas Children's Hospital - Woodlands Campus — Houston, Texas, United States

Full record on ClinicalTrials.gov

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